Manager Scientific Writing

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As the Manager of Scientific Writing, you will provide oversight and supervision of staff performing report generation support of pharmaceutical development studies such as method development and validation, stability, QC, etc.  You will also be able to drive automation as a leader under the Laboratory Informatics organization supporting initiatives within the LIMS reporting tool as well as document repository applications.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Essential Functions:

Manages the daily work activities of the scientific writing staff and frontline leaders to ensure efficient and effective lab support operations. Provides short and long term resource planning in order to assign projects to appropriate and available staff. Evaluates timeliness and quality of deliverables and provide updates to senior management including tracking of KPIs.

Drives automation initiatives to improve accuracy and team efficiency. Supports and liaisons with Informatics for LIMS configurations and client rules engine.

Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.

Compiles laboratory data into a specified format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.

Edits and performs quality control review of reports prepared by Scientific Writers and/or other writers within the organization. Reviews data tables and listings to ensure accuracy.

Organizes processes for writing scientific documents. Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs.

Represents the scientific writing team overall GMP initiatives and work with other department heads on process improvements. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents and ensures that information is available for staff.

Provides assistance and resource information to departmental and laboratory staff. Trains and mentors other scientific writing and laboratory staff in writing skills and procedures for preparing documents.

PPDLABS

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As the Manager of Scientific Writing, you will provide oversight and supervision of staff performing report generation support of pharmaceutical development studies such as method development and validation, stability, QC, etc.  You will also be able to drive automation as a leader under the Laboratory Informatics organization supporting initiatives within the LIMS reporting tool as well as document repository applications.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Essential Functions:

Manages the daily work activities of the scientific writing staff and frontline leaders to ensure efficient and effective lab support operations. Provides short and long term resource planning in order to assign projects to appropriate and available staff. Evaluates timeliness and quality of deliverables and provide updates to senior management including tracking of KPIs.

Drives automation initiatives to improve accuracy and team efficiency. Supports and liaisons with Informatics for LIMS configurations and client rules engine.

Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.

Compiles laboratory data into a specified format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.

Edits and performs quality control review of reports prepared by Scientific Writers and/or other writers within the organization. Reviews data tables and listings to ensure accuracy.

Organizes processes for writing scientific documents. Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs.

Represents the scientific writing team overall GMP initiatives and work with other department heads on process improvements. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents and ensures that information is available for staff.

Provides assistance and resource information to departmental and laboratory staff. Trains and mentors other scientific writing and laboratory staff in writing skills and procedures for preparing documents.

PPDLABS

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to5 years) or equivalent and relevant combination of education, training, & experience.

1 year of leadership responsibility

Knowledge, Skills and Abilities:

Extensive working knowledge of scientific terminology, medical, pharmaceutical and researchconcepts

Demonstrated knowledge of word processing, spreadsheets, table and graph generation and usageof applicable computer software

Extensive knowledge of regulations, ICH, and compendial requirements of the pharmaceuticalindustry

Working knowledge of complex analytical laboratory procedures

Excellent written and oral communication skills

Strong time management and project management skills

Excellent editorial/proofreading skills

Demonstrated leadership abilities

Ability to motivate and train staff individually and in a team environment

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Ableto work upright and stationary and/or standingfor typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technologywith proficiency.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to5 years) or equivalent and relevant combination of education, training, & experience.

1 year of leadership responsibility

Knowledge, Skills and Abilities:

Extensive working knowledge of scientific terminology, medical, pharmaceutical and researchconcepts

Demonstrated knowledge of word processing, spreadsheets, table and graph generation and usageof applicable computer software

Extensive knowledge of regulations, ICH, and compendial requirements of the pharmaceuticalindustry

Working knowledge of complex analytical laboratory procedures

Excellent written and oral communication skills

Strong time management and project management skills

Excellent editorial/proofreading skills

Demonstrated leadership abilities

Ability to motivate and train staff individually and in a team environment

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Ableto work upright and stationary and/or standingfor typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technologywith proficiency.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.